Filgrastim

What it is used for

NYPOZI is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NYPOZI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NYPOZI is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). Patients with Cancer Undergoing Bone Marrow Transplantation NYPOZI is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.

Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NYPOZI is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Patients with Severe Chronic Neutropenia NYPOZI is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NYPOZI is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Side effects, and when to stop

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Splenic Rupture
• Acute Respiratory Distress Syndrome
• Serious Allergic Reactions
• Sickle Cell Disorders
• Glomerulonephritis
• Alveolar Hemorrhage and Hemoptysis
• Capillary Leak Syndrome
• Myelodysplastic Syndrome
• Acute Myeloid Leukemia
• Thrombocytopenia
• Leukocytosis
• Cutaneous Vasculitis
• Large and Medium Vessel Arteritis

Who should not take it

NEUPOGEN is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim.

Storing it

Store NEUPOGEN vial refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage. Do not leave NEUPOGEN vial in direct sunlight. Avoid freezing NEUPOGEN vial; if frozen, thaw in the refrigerator before administration. Discard NEUPOGEN vial if frozen more than once. Do not shake. Transport via a pneumatic tube has not been studied.

Prefilled Syringes (SingleJect ® )

Single-dose, prefilled syringe with 27 gauge, ½ inch needle with an UltraSafe ® Needle Guard, containing 300 mcg/0.5 mL of filgrastim.

• Carton of 1 prefilled syringe (NDC 55513-924-91).
• Carton of 10 prefilled syringes (NDC 55513-924-10, NDC 55513-924-20).

Single-dose, prefilled syringe with 27 gauge, ½ inch needle with an UltraSafe ® Needle Guard, containing 480 mcg/0.8 mL of filgrastim.

• Carton of 1 prefilled syringe (NDC 55513-209-91).
• Carton of 10 prefilled syringes (NDC 55513-209-10, NDC 55513-209-20).

The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).

Store NEUPOGEN prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage. Do not leave NEUPOGEN prefilled syringe in direct sunlight. Avoid freezing NEUPOGEN prefilled syringe; if frozen, thaw in the refrigerator before administration. Discard NEUPOGEN prefilled syringe if frozen more than once. Do not shake. Transport via a pneumatic tube has not been studied.